It should come as no surprise that the volume and diversity of clinical trial data is expected to rapidly increase over the next few years. The proliferation of mobile health tech, real world evidence (RWE), electronic data capture (EDC) systems, etc. in the clinical...
China announced earlier this month that it will begin accepting clinical trial data from other countries, Outsourcing-Pharma.com reports. The new guideline, issued by the General Office of the Communisty Party of China Central Committee and the General Office of the...
Recent comments from FDA officials and industry leaders suggest a shift in the conceptualization of what constitutes reliable clinical research. Data used to make regulatory decisions may soon be pulled from non-traditional data sources outside of standard clinical...
The historic 21st Century Cures Act, written into law last December, is a 362-page bill comprised of several initiatives impacting the life sciences industry. The allocation of $4.8 billion for the “Cancer Moonshot” portion of the bill won over most headlines during...
KMR Group recently concluded an analysis spanning ten years, from 2005 to 2015, that evaluated cycle time performance for more than 17,000 interventional trials. The analysis investigates clinical trial differences by molecule type and shows an increase in both length...
The culture of sharing and openness in the clinical trial data arena is improving – for sure, it’s being talked about. Large pharma and pharma associations are making pledges to make data collected more available. They are being careful to limit disclosure such that...
